MINOXIDIL

Product NDC
68151-2031
11-digit product format
681512031
Labeler code
68151
Product ID
68151-2031_66cce4de-c6bc-42f8-9fdf-6c9814f58152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minoxidil
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA072709
Marketing category
ANDA
Marketing start
1995-12-14
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
3 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-2031IInactivated by FDA2026-08-03
excluded packagepackage68151-203168151-2031-8IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68151-2031-8IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68151-2031-8IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68151-2031-8IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68151-2031-8IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68151-2031-8IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68151-2031-8IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-2031-8IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-2031-8IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-2031-8IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-2031-8IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-2031-8IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-2031-8IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68151-2031-8IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68151-2031-8IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68151-2031-8IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68151-2031-8IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68151-2031-8IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68151-2031-8IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68151-2031-8IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68151-2031-8IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68151-2031-8IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68151-2031-8EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072709-001MINOXIDILMINOXIDIL10MGTABLET / ORALAB1995-12-14
A072709-002MINOXIDILMINOXIDIL2.5MGTABLET / ORALAB1995-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A072709-001AB
A072709-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072709-001MINOXIDIL10MGTABLET / ORALAB1995-12-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A072709-002MINOXIDIL2.5MGTABLET / ORALAB1995-12-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A072709-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072709-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072709-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072709-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072709-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072709-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072709-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072709-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072709-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072709-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072709-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072709-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072709-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072709-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072709-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072709-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072709-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072709-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072709-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A072709-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072709-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072709-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072709-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072709-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072709-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072709-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072709-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A072709-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072709-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072709-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072709-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A072709-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072709-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A072709-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072709-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A072709-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072709-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A072709-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072709-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A072709-002AB1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-2031-82020-01-31C16284748780-19d75b9d0-8ae8-f424-e053-dadaa90a57ceMINOXIDIL TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2031-8MINOXIDIL1 in 1 CUPTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2031MINOXIDIL TABLET [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20160304_032835ab-1c8b-418a-9009-b6ebe58676dc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MINOXIDILMINOXIDILPD-Rx Pharmaceuticals, Inc.5fea137a-bc88-4b24-85db-538c90ad18702026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072709
application number: ANDA072709
MINOXIDILMINOXIDILPD-Rx Pharmaceuticals, Inc.f0dae476-8d0b-4d0c-a505-ad51bf27a1c82026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072709
application number: ANDA072709
MINOXIDILMINOXIDILSun Pharmaceutical Industries, Inc.0354a7f5-5917-44dc-9963-411104008cb52026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072709
application number: ANDA072709
MINOXIDILMINOXIDILBryant Ranch Prepack40da3ec5-39db-42f1-b0d6-39d8521303072024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072709
application number: ANDA072709

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197987minoxidil 2.5 MG Oral TabletPSN032835ab-1c8b-418a-9009-b6ebe58676dc2
197987minoxidil 2.5 MG Oral TabletSCD032835ab-1c8b-418a-9009-b6ebe58676dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2031-8681512031081 in 1 CUPHistorical